Emergent BioSolutions Receives FDA Approval Extending Shelf Life Of BioThrax (Anthrax Vaccine Adsorbed) To 4 Years

Main Category: Bio-terrorism / Terrorism
Also Included In: Regulatory Affairs / Drug Approvals;  Immune System / Vaccines
Article Date: 12 Jun 2009 - 3:00 PDT

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Emergent BioSolutions Inc. (NYSE:EBS) announced that its flagship product, BioThrax® (Anthrax Vaccine Adsorbed), has been granted a shelf life extension from 3 to 4 years by the U.S. Food and Drug Administration (FDA). Based on this approval, Emergent has achieved a contract milestone warranting a payment of approximately $30 million for doses previously delivered to the Strategic National Stockpile (SNS) under the terms of the company's existing BioThrax procurement contracts with the Department of Health and Human Services (HHS). This amount is expected to be recognized as revenue in the second quarter of 2009. In addition, FDA approval of 4-year expiry dating results in an immediate price increase for the future delivery of BioThrax doses under the current contract as well as under the follow-on multi-year contract, valued at $405 million, for the delivery of 14.5 million doses of BioThrax.

"We are pleased that the FDA has approved the 4-year expiry dating of BioThrax as this extends the ability of the U.S. government to store our product in the nation's Strategic National Stockpile," said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. "This is a critically important product feature that we believe will increase the attractiveness of BioThrax to the U.S. government as it increases BioThrax's lifecycle value. We are continuing our efforts to further enhance the attributes of BioThrax, including research towards a further reduction in the vaccination schedule and an expanded label indication for post-exposure prophylaxis. We believe these enhancements, if approved, will advance the U.S. government's preparedness efforts in response to anthrax as a potential weapon of bioterrorism."

Emergent has been pursuing a number of BioThrax product enhancements over the past several years. In addition to FDA approval of 4-year dating for BioThrax, in December 2008, Emergent received FDA approval of a reduced vaccination regimen to a five-dose schedule and a change to an intramuscular route of administration. Emergent continues to research additional enhancements to BioThrax such as a possible further reduction in the vaccination regimen and a potential label expansion to include use as a post-exposure prophylaxis.

To date, Emergent has supplied over 33 million doses of BioThrax to the U.S. government, with additional deliveries to the SNS scheduled through the third quarter of 2011.

About BioThrax

BioThrax is the only FDA-licensed vaccine for the prevention of anthrax infection. It is indicated for the active immunization of adults who are at high risk of exposure to anthrax. BioThrax is manufactured from a culture filtrate, made from a non-virulent strain of Bacillus anthracis. Since 1998, the U.S. government has procured nearly 33.5 million doses of BioThrax. During that time period, more than 8.7 million doses have been administered to more than 2.2 million military personnel. For full FDA-approved prescribing information, please visit www.biothrax.com/prescribinginformation_biothrax_us.pdf.

Important Information About BioThrax®

The most common (>10%) local (injection-site) adverse reactions observed in clinical studies were tenderness, pain, erythema and arm motion limitation. The most common (>5%) systemic adverse reactions were muscle aches, fatigue and headache. Serious allergic reactions, including anaphylactic shock, have been observed during post-marketing surveillance in individuals receiving BioThrax.

Pregnant women should not be vaccinated unless the potential benefits of vaccination have been determined to outweigh the potential risk to the fetus. If BioThrax is used during pregnancy, or if the patient becomes pregnant during the immunization series, the patient should be apprised of the potential hazard to the fetus. This product should be administered with caution to persons with a possible history of latex sensitivity since the vial stopper contains dry natural rubber.

Vaccination with BioThrax should be avoided by individuals with a history of anaphylactic or anaphylactic-like reaction following a previous dose of BioThrax.

BioThrax is not licensed for use in a post-exposure setting. The safety and efficacy of BioThrax have not been established in pregnant women, nursing mothers, pediatric populations or geriatric populations.

BioThrax may not protect all individuals vaccinated, particularly patients with impaired immune responses due to congenital or acquired immunodeficiency, or immunosuppressive therapy. Individuals are not considered protected until they have completed the full vaccination series.

Source
Emergent BioSolutions Inc.